Assistant Manager QA

Key Responsibilities of Assistant Manager QA

✅ Quality Management System (QMS)

• Manage
  and review QMS elements including Change Control, CAPA, Deviations,
  Incidents, OOS, OOT, Market Complaints.
  
• Monitor
  timely closure of QMS activities and ensure effectiveness of implemented
  CAPAs.
  
• Conduct
  periodic quality reviews and risk assessments.
  

✅ Documentation & Compliance

• Review
  and approval of SOPs, BMR/BPR, MFR, STP, Specifications.
  
• Ensure
  compliance to WHO -GMP, Schedule M, ICH Q -series guidelines.
  
• Control
  issuance, archival, and retrieval of QA documents.
  

Requirements

✅ Validation & Qualification

• Support Process Validation, Cleaning Validation, Equipment Qualification activities.
  
• Review
  validation protocols, reports, and coordinate execution with
  cross -functional teams.
  
• Monitor
  stability studies and ensure compliance with approved protocols.
  

✅ In -Process & Shop Floor QA

• Conduct line clearance at dispensing, granulation, compression, coating,
  packing areas.
  
• Perform in -process checks as per defined frequencies.
  
• Ensure
  effective implementation of cGMP & data integrity practices.
  

✅ Audit Readiness &
Compliance

• Participate
  in internal audits, customer audits, WHO -GMP audits, and regulatory
  inspections.
  
• Prepare
  audit documents, track observations, and ensure timely closure of audit
  CAPAs.
  
• Coordinate
  with cross -functional teams for audit preparedness.
  

✅ Training & Team Support

• Conduct
  GMP, GDP, Data Integrity, and QMS -related training sessions.
  
• Guide
  and mentor junior QA executives/officers.